Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary arterial hypertension, Inhaled iloprost, Quality of life
Brief summary
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis. Typical clinical measures and quality of life will be prospectively followed in 12 months period.
Interventions
DRUGInhaled iloprost (Ventavis, BAYQ6256)
Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pulmonary arterial hypertension in WHO functional class III or IV * Age 18+ * Patients newly treated with Ventavis or switched from sildenafil
Exclusion criteria
* Retrospective documentation is not allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of the exercise capacity as measured by 6-minutes walking distance | 3, 6, 9 and 12 months vs. baseline |
Secondary
| Measure | Time frame |
|---|---|
| Changes of functional capacity as measured by WHO classification system | 3, 6, 9 and 12 months vs. baseline |
| Changes of pulmonary haemodynamics | 3, 6, 9 and 12 months vs. baseline |
| Changes of serum level of natriuretic peptide B | 3, 6, 9 and 12 months vs. baseline |
| Changes of depression score over time | 3, 6, 9 and 12 months vs. baseline |
| Changes in cardiac echo parameters | 3, 6, 9 and 12 months vs. baseline |
| Number of patients with treatment-emergent adverse events | Up to 12 months |
| Changes of Quality of Life score | 3, 6, 9 and 12 months vs. baseline |
Countries
Poland
Outcome results
None listed